PATCH, PLEDGET AND INTRACARDIAC


Device Classification Name

patch, pledget and intracardiac, petp, ptfe, polypropylene

510(k) Number K111187
Device Name PATCH, PLEDGET AND INTRACARDIAC
Applicant
CORMATRIX CARDIOVASCULAR, INC.
155 moffett park drive
suite 210
sunnyvale, 
CA 
94089

Applicant Contact kit cariquitan
Correspondent
CORMATRIX CARDIOVASCULAR, INC.
155 moffett park drive
suite 210
sunnyvale, 
CA 
94089

Correspodent Contact kit cariquitan
Regulation Number 870.3470
Classification Product Code
DXZ  
Date Received 04/27/2011
Decision Date 07/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No